- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07715578
Effect of Balance Exercises on Performance in Amputee Football Players (AF-BALANCE)
Evaluation of the Effect of Balance Exercises on the Performance of Amputee Football Players
This randomized controlled study evaluated the effects of an 8-week balance and trunk stabilization exercise program on balance and functional performance in male amputee football players. Twenty athletes aged 18 to 45 years were randomly assigned to an intervention group or a control group.
The intervention group completed trunk stabilization, proprioceptive balance, and sport-specific plyometric exercises twice weekly in addition to routine football training. The control group continued routine football training only. Balance and functional mobility were assessed before and after the 8-week period using the Berg Balance Scale, the L-Test of Functional Mobility, and the Figure-of-8 Walk Test.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Sakarya, Turkey (Türkiye)
- Amputee Football Training Facility
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male amputee football players aged 18 to 45 years.
- Unilateral lower-limb amputation.
- Classification as A1 according to the amputee football classification system.
- Active participation in amputee football for at least 6 months.
- Ability and willingness to participate in the study.
- Provision of written informed consent.
Exclusion Criteria:
- Bilateral lower-limb amputation.
- Insufficient experience in using crutches or a prosthesis.
- Any acute injury or serious neurological, cardiovascular, or other medical condition that could prevent completion of the L-Test of Functional Mobility, Figure-of-8 Walk Test, or exercise program.
- An active injury or rehabilitation condition preventing participation in football training.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Group
|
|
|
Experimental: Balance Exercise Group
|
An 8-week exercise program performed twice weekly in addition to routine football training.
The program included trunk stabilization, proprioceptive balance exercises, and sport-specific plyometric jumping and agility exercises.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in L-Test of Functional Mobility Completion Time
Time Frame: Baseline and 8 weeks
|
Functional mobility, speed, agility, and dynamic balance were assessed using the L-Test of Functional Mobility.
Participants completed three trials, and the mean completion time was recorded in seconds.
Lower completion times indicate better functional performance.
Change was calculated by comparing the assessment performed at baseline with the assessment performed after the 8-week intervention.
|
Baseline and 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Figure-of-8 Walk Test Completion Time
Time Frame: Baseline and 8 weeks
|
Dynamic balance, agility, postural control, and directional change ability were assessed using the Figure-of-8 Walk Test.
Participants completed three trials, and the mean completion time was recorded in seconds.
Lower completion times indicate better performance.
Change was assessed from baseline to the end of the 8-week intervention.
|
Baseline and 8 weeks
|
|
Change in Figure-of-8 Walk Test Step Count
Time Frame: Baseline and 8 weeks
|
Movement efficiency during the Figure-of-8 Walk Test was assessed by recording the number of steps required to complete the test.
Participants completed three trials, and the mean step count was calculated.
A lower number of steps indicates greater movement efficiency.
Change was assessed from baseline to the end of the 8-week intervention.
|
Baseline and 8 weeks
|
|
Change in Berg Balance Scale Total Score
Time Frame: Baseline and 8 weeks
|
Static and functional balance were assessed using the Berg Balance Scale.
The scale contains 14 items scored from 0 to 4, providing a total score ranging from 0 to 56.
Higher scores indicate better balance and lower fall risk.
Change was assessed from baseline to the end of the 8-week intervention.
|
Baseline and 8 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- NISAMAKTAY
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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